MAUDE Adverse Event Report: ENVIZION MEDICAL, LTD. ENVUE FEEDING TUBE PLACEMENT SYSTEM; NG FEEDING TUBE

Model Number	ENV-20000
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On thursday, 06.15.2023, we received the placement files and conducted an analysis.In both cases the red arrow and the deviation! message appeared on the screen indicating that the feeding tube was deviating towards the lungs.However, the users continued to advance the feeding tube.Additional information was received on 7/12/2023 from the site via email indicating that they believed the device was a contributing factor to the event and therefore the complaint is being re-opened for further investigation.
Event or Problem Description
A lung placement occurred on (b)(6) 2023.Intervention was required to remove the feeding tube from the lung to prevent injury.Based on the information provided no actual injury occurred to the patient.
Event or Problem Description
A lung placement occurred on (b)(6) 2023.

• Brand Name: ENVUE FEEDING TUBE PLACEMENT SYSTEM
• Common Device Name: NG FEEDING TUBE
• Manufacturer (Section D): ENVIZION MEDICAL, LTD.; 26 habarzel; tel aviv, il 69710 36; IS 6971036
• Manufacturer (Section G): ERI GROUP; 433 park point dr.; suite 140; golden CO 80401
• Manufacturer Contact: john mann ; 26 habarzel st.; tel-aviv, israel 69710-36 ; IS 6971036
• MDR Report Key: 17450991
• Report Number: 3011548489-2023-00002
• Device Sequence Number: 7537567
• Product Code: KNT
• UDI-Device Identifier: B483EVN200000
• UDI-Public: B483EVN200000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ENV-20000
• Device Catalogue Number: ENV-20000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male